Design Control for Medical Device Professionals

Because of its comprehensive overview, this course will be most valuable to medical device industry engineers, engineering managers, regulatory affairs professionals, scientists, and quality engineers, whether in product development, manufacturing, quality assurance, or regulatory affairs, who are new to the industry or to their current position and do not have an in-depth knowledge of the Design Control and its workings. The program can also be customized for more experienced personnel, including middle and upper management, to update and broaden their knowledge of FDA’s Design Control requirements.

Learning Objectives

Upon completion of this course, you will have gained an understanding of how to effectively meet the requirements of design control for medical devices. An emphasis will be placed on effective design strategy – strategy is very important to avoid spending unnecessary time and money on an ineffective design control process. The first day will cover the general context for design control, required procedures, and the discussion of the general design control procedure. The second day will discuss additional regulatory topics and procedures. Manufacturing transfer and general quality system topics will be covered as they relate to the design process. Included with this course are extensive Course Notes that are frequently used by attendees as reference material once the course is completed.

Course Description

This continually updated course covers current FDA regulatory compliance with respect to developing medical devices. A focus will be placed on basic regulation and the FDA's supplemental guidelines.

Among the topics to be discussed are: Context of design control within the overall quality system and regulation, design control procedures, forms, records, safety/risk management strategies, documentation strategies, manufacturing transfer strategies, and strategies for integrating general quality system procedures into design control.